Ablative Solutions announced today that its TARGET BP I pivotal trial evaluating its Peregrine System kit met its primary endpoint. The trial evaluates alcohol-mediated renal denervation to treat hypertension with the Peregrine System. Wakefield, Massachusetts-based Ablative Solutions reported a statistically significant difference in 24-hour ambulatory blood pressure between treatment and sham procedure at three months. […]
Clinical Trials
UroMems reports positive feasibility data for smart urology implant
UroMems today announced that it the treatment cohort in a feasibility study of its UroActive system reached six-month primary endpoints. Grenoble, France-based UroMems designed its smart UroActive implant to treat stress urinary incontinence (SUI). The company says it’s the first smart, automated artificial urinary sphincter (AUS) to treat SUI. Powered by a MyoElectroMechanical system (MEMS), […]
J&J’s Biosense Webster treats first patients in dual-energy AFib ablation trial
Johnson & Johnson’s Biosense Webster today announced the first completed patient cases in a study of its dual-energy ablation catheter. Biosense Webster designed the ThermoCool SmartTouch SF to deliver both radiofrequency (RF) and pulsed-field ablation (PFA) energy. The SmartPulse pivotal study evaluates the dual-energy system in the treatment of paroxysmal AFib. AFib ablation has become […]
Imperative Care begins first-in-human study of neurovascular stent
Imperative Care announced today that it initiated a first-in-human clinical study for its novel neurovascular stent system. Campbell, California-based Imperative Care designed the system to only require single antiplatelet therapy for patients undergoing stent-assisted treatment of wide-neck intracranial aneurysms. Dr. Nobuyuki Sakai successfully treated the first three patients enrolled in the study. Sakai serves as […]
Vivasure treats first patients with percutaneous vessel closure device
Vivasure Medical announced today that the first patient received treatment with its PerQseal Elite large-hole closure system. Galway, Ireland-based Vivasure designed the latest-generation PerQseal Elite for percutaneous vessel closure. It leverages the legacy platform’s safety profile and ease of use while allowing for faster delivery. The new system also improves performance in calcium and the […]
Cognito Therapeutics reports non-invasive neuromod data for treating Alzheimer’s
Cognito Therapeutics today announced the publication of MRI imaging data from a study of its non-invasive neurostimulation technology. The company published MRI imaging data from the Phase 2 OVERTURE study in the Journal of Alzheimer’s Disease. Cambridge, Massachusetts-based Cognito evaluated patients with mild-moderate Alzheimer’s disease receiving one-hour daily treatment. Patients underwent treatment with the Cognito gamma […]
Microbot Medical is a step closer to an FDA IDE submission
Microbot Medical today announced the successful completion of its pivotal pre-clinical study of its Liberty endovascular robotic surgical system. The study, performed under good laboratory practice (GLP) and essential for the company’s investigational device exemption (IDE) submission, took place under rigorous FDA guidelines. The study involved pigs. In this study, three interventional radiologists performed 96 […]
Micro Medical Solutions completes enrollment in vascular stent study
Micro Medical Solutions announced today that it completed enrollment in a U.S. pivotal clinical study of its MicroStent system. Wilmington, Massachusetts-based Micro Medical set up its study to evaluate MicroStent’s safety and effectiveness. The study pits the stent against the current standard of care, percutaneous transluminal angioplasty (PTA). MicroStent, a vascular stent, was designed to […]
Kandu Health has positive data for stroke recovery platform
Imperative Care’s Kandu Health today announced positive data supporting its digital post-acute stroke treatment platforms. Campbell, California-based Kandu shared data at two conferences. It presented results from a study of its remote post-acute service at the Society of Vascular and Interventional Neurology (SVIN) Annual Meeting. The company presented feasibility data on its navigation platform at […]
Noah Medical announces first uses of surgical robot in Asia
Noah Medical announced today that a hospital in Hong Kong conducted the first use of its Galaxy surgical robot system in Asia. Dr. Calvin Ng and Dr. Rainbow Lau performed the first use of Galaxy at Prince of Wales Hospital. The procedure marks the beginning of the first clinical trial of the robotic bronchoscopy system […]
Qnovia has positive results for inhaled smoking cessation therapy
Qnovia announced positive results from its first-in-human study for the QN-01 inhaled smoking cessation therapy. Richmond, Virginia-based Qnovia develops the RespiRx drug delivery platform that leverages a vibrating mesh nebulizer. CEO Brian Quigley explained the technology to Drug Delivery Business News last year. The company designed the QN-01 therapy to meet the need for safe and effective […]